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伤害敏感指数及镇痛指数与全身麻醉患者疼痛程度变化的相关性研究
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注册号：

Registration number：

 ChiCTR2400091682 

最近更新日期：

Date of Last Refreshed on：

 2024-11-01 09:28:04 

注册时间：

Date of Registration：

 2024-11-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

伤害敏感指数及镇痛指数与全身麻醉患者疼痛程度变化的相关性研究

Public title：

A study of the correlation between the injury sensitivity index and analgesia index and changes in pain levels in patients under general anaesthesia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

伤害敏感指数及镇痛指数与全身麻醉患者疼痛程度变化的相关性研究

Scientific title：

A study of the correlation between the injury sensitivity index and analgesia index and changes in pain levels in patients under general anaesthesia

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

张莹 

研究负责人：

张莹 

Applicant：

Zhang Ying 

Study leader：

Zhang Ying 

申请注册联系人电话：

Applicant telephone：

 +86 153 5502 8365

研究负责人电话：

Study leader's
telephone：

+86 153 5502 8365

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 237368558@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 237368558@qq.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

浙江省杭州市临平区迎宾路369号

研究负责人通讯地址：

浙江省杭州市临平区迎宾路369号

Applicant address：

No.369 Yingbin Road, Linping District, Hangzhou, Zhejiang Province, China

Study leader's address：

No.369 Yingbin Road, Linping District, Hangzhou, Zhejiang Province, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

杭州市临平区第一人民医院

Applicant's institution：

The First People's Hospital of Linping District, Hangzhou

研究负责人所在单位：

杭州市临平区第一人民医院

Affiliation of the Leader：

The First People's Hospital of Linping District, Hangzhou

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 临平一院伦审2024研第0198号

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

杭州市临平区第一人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of the First People's Hospital of Linping District, Hangzhou, China

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-10-24 00:00:00

伦理委员会联系人：

谢明华

Contact Name of the ethic committee：

Xie Minghua

伦理委员会联系地址：

浙江省杭州市临平区迎宾路369号

Contact Address of the ethic committee：

No.369 Yingbin Road, Linping District, Hangzhou, Zhejiang Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 153 7200 2273

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

杭州市临平区第一人民医院

Primary sponsor：

The First People's Hospital of Linping District, Hangzhou

研究实施负责（组长）单位地址：

浙江省杭州市临平区迎宾路369号

Primary sponsor's address：

No.369 Yingbin Road, Linping District, Hangzhou, Zhejiang Province, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江

市(区县)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

杭州市临平区第一人民医院

具体地址：

浙江省杭州市临平区迎宾路369号

Institution
hospital：

The First People's Hospital of Linping District, Hangzhou

Address：

No.369 Yingbin Road, Linping District, Hangzhou, Zhejiang Province, China

经费或物资来源：

自筹

Source(s) of funding：

self-finance

研究疾病：

腹腔镜下胆囊切除术  

Target disease：

laparoscopic cholecystectomy

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究旨在深入探讨并对比镇痛指数（PTi）与伤害敏感指数（IoC2）的动态变化与全身麻醉过程中患者疼痛程度变化之间的内在联系及其临床意义，以期为优化麻醉管理和疼痛治疗策略提供科学依据。  

Objectives of Study：

The aim of this study was to deeply investigate and compare the intrinsic connection between the dynamic changes of the analgesic index (PTi) and the injury sensitivity index (IoC2) and the changes of the patients' pain level during general anaesthesia as well as their clinical significance, with a view to providing a scientific basis for optimising anaesthesia management and pain treatment strategies.

药物成份或治疗方案详述：

研究方案 1.操作前 术前对符合纳入标准的患者完成访视及宣教，充分告知本次研究目的，宣教麻醉的基本流程、风险，与患者或家属签署知情同意书。采用随机数字表法将病人分为2组（A组和B组）,每组30例。A组行镇痛指数（PTi）监测，B组行伤害敏感指数（IoC2）监测。 2.操作实施 所有患者禁食8小时、禁水2小时以上。 麻醉前准备：2组患者均采用全凭静脉麻醉，无术前用药。患者入室后开放静脉通路，输注复方氯化钠液。2组均进行无创血压、心电图、脉搏血氧饱和度、呼吸末二氧化碳浓度监测。A组清洁前额皮肤后，按标准连接电极，采用麻醉全深度监护仪组监测镇静深度（WLi）和PTI。B组清洁前额皮肤后，按标准连接电极，采用 Angle-6000脑电麻醉深度多参数监护仪（深圳市威浩康医疗器械有限公司）进行脑电意识指数（IoC1）和IoC2的监测。 麻醉诱导：两组麻醉诱导均为静脉推注咪达唑仑0.04mg/kg，依托咪酯0.2mg/kg，舒芬太尼0.5ug/kg，顺式阿曲库铵0.2mg/kg。A组调控丙泊酚浓度直至WLi35-45，PTI为40-60时进行插管。B组调控丙泊酚浓度直至IoC1为35-45，IoC2为23-35时进行插管。 麻醉维持：术中2组均采用丙泊酚镇静和瑞芬太尼镇痛的全凭静脉麻醉维持麻醉，A组以WLi和PTI的监测指标变化调控麻醉药物用量，B组以IoC1和IoC2的监测指标变化调控麻醉药物用量。调控规则如下：术中控制IoC1位于40-60范围，IoC2位于30-50范围， WLi位于40-60范围，PTI位于40-60范围。根据需要追加肌肉松弛药。两组病人均在手术结束前半小时内给予非甾体类抗炎药物帕瑞昔布钠镇痛，术毕送入麻醉恢复室复苏。 麻醉和操作期间监测生命体征，记录两组患者术前一般情况、手术时间和麻醉时间。记录丙泊酚和瑞芬太尼的用量，记录患者术后苏醒及拔管情况。记录气管插管、切皮、气腹建立、三项操作前 1 min 和操作即刻的 IoC2、PTi、MAP、HR，并将两者的差值定义为基础波动值; 将操作即刻后 2 min 内各项指标的最大值与操作即刻的差值定义为波动幅度(Δ)；计算各个指标Δ值与基础波动值的比值；记录有无麻醉相关并发症。记录患者术后24h的不良反应发生情况，包括: 呼吸抑制、体温变化、 寒战、恶心、呕吐等情况。 激素和炎症因子检测：在麻醉诱导前、切皮后15min、苏醒后即刻时抽取桡动脉血 3～5ml，采用酶联免疫吸附试验（ELISA）方法检测患者血清炎症因子（IL-6、IL-10）的浓度。  

Description for medicine or protocol of treatment in detail：

Research programme 1. Pre-operation Before the operation, patients who met the inclusion criteria were visited and educated, fully informed of the purpose of this study, educated about the basic procedures and risks of anaesthesia, and signed an informed consent form with the patients or their families. The patients were divided into 2 groups (Group A and Group B) using the random number table method, with 30 cases in each group.Group A was monitored with the analgesic index (PTi), and Group B was monitored with the injury sensitivity index (IoC2). 2. Operation implementation All patients were fasted for 8 hours, and water was forbidden for more than 2 hours. Anaesthesia pre-preparation: patients in the 2 groups were under general intravenous anaesthesia without preoperative medication. After the patients were admitted to the room, intravenous access was opened and compound sodium chloride solution was infused.Non-invasive blood pressure, electrocardiogram, pulse oximetry and end-expiratory carbon dioxide concentration were monitored in both groups.Group A cleaned the forehead skin, connected the electrodes according to the standard, and used the anaesthesia full-depth monitor group to monitor the depth of sedation (WLi) and PTI.Group B cleaned the forehead skin, connected the electrodes according to the standard, and used Angle-6000 EEG anaesthesia depth multi-parameter monitor (Shenzhen Weihao Kang Medical Equipment Co., Ltd.) for the monitoring of EEG index of consciousness (IoC1) and IoC2. Induction of anaesthesia: In both groups, anaesthesia was induced by intravenous infusion of midazolam 0.04 mg/kg, etomidate 0.2 mg/kg, sufentanil 0.5ug/kg, cisatracurium 0.2 mg/kg. group A was intubated by regulating the concentration of propofol until the WLi was 35-45, and the PTI was 40-60. group B was intubated by regulating the concentration of propofol until the IoC1 was 35-45, the IoC2 was 23-35, and the IoC2 was 23-45. Group B was intubated when IoC1 was 35-45 and IoC2 was 23-35. Maintenance of anaesthesia: During the operation, both groups used total intravenous anaesthesia with propofol sedation and remifentanil analgesia to maintain anaesthesia. Group A regulated the dosage of anaesthesia drugs by the changes in the monitoring indexes of WLi and PTI, and Group B regulated the dosage of anaesthesia drugs by the changes in the monitoring indexes of IoC1 and IoC2. The regulation rules were as follows: intraoperative control of IoC1 in the range of 40-60, IoC2 in the range of 30-50, WLi in the range of 40-60, and PTI in the range of 40-60. Additional muscle relaxants were administered as needed. In both groups, patients were given the non-steroidal anti-inflammatory drug parecoxib sodium for analgesia up to half an hour before the end of the operation, and were taken to the anaesthesia recovery room for resuscitation at the end of the operation. Vital signs were monitored during anaesthesia and operation and preoperative general condition, duration of operation and duration of anaesthesia were recorded in both groups. The dosages of propofol and remifentanil were recorded, and the patients' postoperative awakening and extubation were recorded. The IoC2, PTi, MAP and HR of tracheal intubation, skin incision, pneumoperitoneum establishment, 1 min before and immediately after the three operations were recorded, and the difference between them was defined as the basal fluctuation value; the difference between the maximal value of each index within 2 min after the immediate operation and the immediate operation was defined as the amplitude of fluctuation (Δ); the ratio of Δ value of each index to the basal fluctuation value was calculated; and the presence or absence of anaesthesia-related complications was recorded. The incidence of adverse reactions, including respiratory depression, temperature change, chills, nausea, and vomiting, was recorded 24 hours after the operation. Hormone and inflammatory factor tests: 3-5 ml of radial artery blood was drawn before the induction of anaesthesia, 15 min after skin incision, and immediately after awakening, and the concentrations of serum inflammatory factors (IL-6, IL-10) were measured by enzyme-linked immunosorbent assay (ELISA). 

纳入标准：

Inclusion criteria

排除标准：

1.合并心肺脑疾病、糖尿病，嗜铬细胞瘤等内分泌系统疾病者； 2.既往异常手术麻醉恢复史； 3.既往有高血压、肝肾功能损害、严重过敏史、惊厥史； 4.既往有神经、精神系统疾病，长期服用大量镇静剂、抗抑郁药或镇痛药； 5.既往有酗酒史或药物依赖史； 6.存在交流障碍及其他原因不易合作者； 7.存在对相关麻醉药物过敏或有禁忌症者。

Exclusion criteria：

1. Combined cardiopulmonary and cerebral diseases, diabetes mellitus, pheochromocytoma and other endocrine system diseases; 2. Previous history of recovery from abnormal surgical anaesthesia; 3. Previous history of hypertension, liver and kidney function damage, history of severe allergy, history of convulsion; 4. Previous neurological and psychiatric system diseases, long-term use of large amounts of sedatives, antidepressants or analgesics; 5.Previous history of alcoholism or drug dependence; 6.Presence of communication disorder and other reasons for not easy to co-operate; 7.Those with allergy or contraindication to relevant anaesthesia drugs.

研究实施时间：

Study execute time：

从 From 2024-11-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-11-01 00:00:00 至 To 2024-12-31 00:00:00

干预措施：

Interventions：

组别：

IoC2组

样本量：

 30

Group：

IoC2 group

Sample size：

干预措施：

采用伤害敏感指数（IoC2)监测镇痛深度

干预措施代码：

Intervention：

Monitoring depth of analgesia using IoC2

Intervention code：

组别：

PTI组

样本量：

 30

Group：

PTI group

Sample size：

干预措施：

采用镇痛指数（PTI）监测镇痛深度

干预措施代码：

Intervention：

Monitoring depth of analgesia using PTI

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

 杭州市 

Country：

China

Province：

Zhejiang Province

City：

Hangzhou

单位(医院)：

 杭州市临平区第一民医院 

单位级别：

 三乙 

Institution
hospital：

Hangzhou Linping District First Civil Hospital

Level of the institution：

Tertiary B

测量指标：

Outcomes：

指标中文名：

伤害敏感指数

指标类型：

主要指标

Outcome：

Index of consciousness2

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

镇痛指数

指标类型：

主要指标

Outcome：

Pain Threshold index

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

平均血压

指标类型：

次要指标

Outcome：

Average blood pressure

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

心率

指标类型：

次要指标

Outcome：

Pulse rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 60 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

随机数字表法。将调查总体单位编号；在随机号码表上任意规定抽样的起点和抽样的顺序；研究者依次从随机号码表上抽取样本单位号码。凡是抽到编号范围内的号码，就是样本单位的号码，一直到抽满为止。

Randomization Procedure (please state who generates the random number sequence and by what method)：

Random number table method. The overall units of the survey are numbered; the starting point of the sample and the order of sampling are specified arbitrarily on the random number table; the researcher draws the numbers of the sample units sequentially from the random number table. Any number drawn within the numbered range is the number of the sample unit, and this is done until the sample is full.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

对受试者设盲

Blinding：

Blinding of subjects

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

N/A

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

采用EXCEL和SPSS管理数据

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data management using EXCEL and SPSS

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-11-01 09:27:45
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